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CLIMAGEST 1MG TABLETS

Active substance(s): ESTRADIOL VALERATE / NORETHISTERONE

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Climagest® 1mg and 2mg Tablets
Mericomb® 1mg and 2mg Tablets
(estradiol valerate, norethisterone)
Your medicine is known by one of the above names, but will be referred to
as Climagest throughout this:
Patient Information Leaflet
Read all of this leaflet carefully, before you start taking this medicine
because it contains important information for you.
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others.
It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects talk to your doctor or pharmacist. This includes
any possible side effects not listed in this leaflet.

• Hereditary angioedema or episodes of rapid swelling of the hands, feet,
face, lips, eyes, tongue, throat (airway blockage) or digestive tract.
Stop taking Climagest and see a doctor immediately.

What is in this leaflet:
1) What Climagest is and what it is used for
2) What you need to know before you take Climagest
3) How to take Climagest
4) Possible side effects
5) How to store Climagest
6) Contents of the pack and other information

If you notice any of the following when taking HRT:
– Any of the conditions mentioned in the ‘Do Not take Climagest’ section
– Yellowing of your skin or the whites of your eyes (jaundice). These may
be signs of a liver disease
– A large rise in your blood pressure (symptoms may be headache,
tiredness, dizziness)
– Migraine-like headaches which happen for the first time, with or without
disturbed vision. Headaches like these can be an early sign of a stroke. If
you have already had a stroke, talk with your doctor about whether the
benefits of the treatment outweigh the possibly increased risk.
– If you get pain in your chest that spreads to your arm or neck. This pain
may be a sign of heart disease.
– If you become pregnant
– If you notice signs of a blood clot, such as:
ƒ painful swelling and redness of the legs
ƒ sudden chest pain
ƒ difficulty in breathing

1) What Climagest is and what it is used for

For more information, see ‘Blood clots in a vein (thrombosis)’

Climagest is a Hormone Replacement Therapy (HRT). It contains two types
of female hormones, an oestrogen and a progestogen. Climagest is used in
postmenopausal women with at least 6 months since their last natural
period.
Oestradiol valerate is identical to the natural female hormone oestrogen.
This hormone is produced by the ovaries before the menopause.
Norethisterone belongs to the group of hormones known as progestogens.
It has effects similar to the natural female hormone progesterone, also
produced by the ovaries before the menopause.

Note: Climagest is not a contraceptive. If it is less than 12 months since
your last menstrual period or you are under 50 years old, you may still need
to use additional contraception to prevent pregnancy. Speak to your doctor
for advice.

Climagest is used for:
Relief of symptoms occurring after menopause
Menopause occurs naturally in all women, usually between the ages of 45
and 55 years. It occurs also in younger women who have their ovaries
removed by surgery. During the menopause, the amount of the oestrogen
produced by a woman’s body drops. This can cause unpleasant symptoms
such as hot face, neck and chest (“hot flushes”), sleep problems, irritability
and depression. Some women also have problems with urine control or
dryness of the vagina, which may cause discomfort during or after sexual
intercourse.

Taking oestrogen-only HRT will increase the risk of excessive thickening of
the lining of the womb (endometrial hyperplasia) and cancer of the womb
lining (endometrial cancer).

Climagest alleviates these symptoms after menopause. You will only be
prescribed Climagest if your symptoms seriously hinder your daily life.
If oestrogen is taken on its own, there is a greater risk of abnormal growth
of the womb lining (endometrial hyperplasia) and endometrial cancer. The
norethisterone in the white Climagest tablet reduces these risks in women
who still have their womb.

2) What you need to know before you take Climagest
Medical history and regular check-ups
The use of HRT carries risks which need to be considered when deciding
whether to start taking it, or whether to carry on taking it.
The experience in treating women with a premature menopause (due to
ovarian failure or surgery) is limited. If you have a premature menopause
the risks of using HRT may be different. Please talk to your doctor.
Before you start (or restart) Climagest, your doctor will ask you about your
own and your family’s medical history. Your doctor may decide to perform a
physical examination. This may include an examination of your breasts
and/or an internal examination, if necessary. He/she should tell you what
kind of changes in the breast you should look out for and may advise you to
have a breast X-ray (a mammogram).
Once you have started on Climagest you should see your doctor for regular
check-ups (at least once a year). At these check-ups, discuss with your
doctor the benefits and risks of continuing with Climagest.
Go for regular breast screening, as recommended by your doctor.
Do not take Climagest
If any of the following applies to you. If you are not sure about any of the
points below, talk to your doctor before taking Climagest,
• if you have or have ever had breast cancer, or if you are suspected of
having it;
• if you have cancer which is sensitive to oestrogens, such as cancer of
the womb lining (endometrium), or if you are suspected of having it;
• if you have any unexplained vaginal bleeding;
• if you have excessive thickening of the womb lining (endometrial
hyperplasia) that is not being treated;
• if you have severe kidney disease;
• if you have or have ever had a blood clot in a vein (thrombosis), such as
in the legs (deep venous thrombosis) or the lungs (pulmonary embolism);
• if you have a blood clotting disorder (such as protein C, protein S, or
antithrombin deficiency);
• if you have or recently have had a disease caused by blood clots in the
arteries, such as a heart attack, stroke or angina;
• if you have or have ever had a liver disease and your liver function tests
have not returned to normal;
• if you have a rare blood problem called “porphyria” which is passed down
in families (inherited);
• if you are allergic (hypersensitive) to oestradiol valerate or norethisterone
or any of the other ingredients of Climagest (listed in section 6);
• if you are pregnant, or think you might be.
If any of the above conditions appear for the first time while taking
Climagest, stop taking it at once and consult your doctor immediately.
When to take special care with Climagest
Tell your doctor if you have ever had any of the following problems,
before you start the treatment, as these may return or become worse during
treatment with Climagest. If so, you should see your doctor more often for
check-ups.
• Fibroids inside your womb
• Growth of womb lining outside your womb (endometriosis) or a history
of excessive growth of the womb lining (endometrial hyperplasia)
• Increased risk of developing blood clots (see “Blood clots in a vein
(thrombosis)”)
• Increased risk of getting an oestrogen-sensitive cancer (such as having
a mother, sister or daughter or grandmother who has had breast cancer),
• High blood pressure
• A liver disorder, such as a benign liver tumour (liver adenoma)
• Diabetes
• Gallstones
• Migraine or severe headaches
• A disease of the immune system that affects many organs of the body
(Systemic lupus erythematosus, SLE)
• Epilepsy
• Asthma
• A disease affecting the eardrum and hearing (otosclerosis)
• A very high level of fat in your blood (triglycerides)
• Fluid retention due to cardiac or kidney problems
• Hypothyroidism (a condition in which your thyroid gland fails to produce
enough thyroid hormone and for which you are treated with thyroid
hormone replacement therapy)

HRT and cancer
Excessive thickening of the lining of the womb (endometrial
hyperplasia) and cancer of the lining of the womb (endometrial
cancer)

The progestogen in Climagest protects you from this extra risk.
In women who still have a womb and who are not taking HRT, on average,
5 in 1000 will be diagnosed with endometrial cancer between the ages of 50
and 65.
For women aged 50 to 65 who still have a womb and who take oestrogenonly HRT, between 10 and 60 women in 1000 will be diagnosed with
endometrial cancer (i.e. between 5 and 55 extra cases), depending on the
dose and for how long it is taken.
Irregular bleeding
You may have irregular bleeding or drops of blood (spotting) during the first
3–6 months of taking Climagest. However, if the irregular bleeding:
– carries on for more than the first 6 months
– starts after you have been taking Climagest for more than 6 months
– carries on after you have stopped taking Climagest
– if you have painful menstrual periods
See your doctor as soon as possible.
Breast cancer
Evidence suggests that taking combined oestrogen-progestogen and
possibly also oestrogen-only HRT increases the risk of breast cancer. The
extra risk depends on how long you take HRT. The additional risk becomes
clear within a few years. However, it returns to normal within a few years (at
most 5) after stopping treatment.
Compare
Women aged 50 to 79 who are not taking HRT, on average, 9 to 17 in 1000
will be diagnosed with breast cancer over a 5-year period. For women aged
50 to 79 who are taking oestrogen-progestogen HRT over 5 years, there will
be 13 to 23 cases in 1000 users (i.e. an extra 4 to 6 cases).
Regularly check your breasts. See your doctor if you notice any
changes such as:
• dimpling of the skin
• change in the nipple
• any lump you can see or feel
Ovarian cancer
Ovarian cancer is rare. A slightly increased risk of ovarian cancer has been
reported in women taking HRT for at least 5 to 10 years.
Women aged 50 to 69 who are not taking HRT, on average about 2 women
in 1000 will be diagnosed with ovarian cancer over a 5-year period. For
women who have been taking HRT for 5 years, there will be between 2 and
3 cases per 1000 users (i.e. up to 1 extra case).
Effect of HRT on heart and circulation
Blood clots in a vein (thrombosis)
The risk of blood clots in the veins is about 1.3 to 3- times higher in HRT
users than in non-users, especially during the first year of taking it.
Blood clots can be serious, and if one travels to the lungs, it can cause
chest pain, breathlessness, fainting or even death.
You are more likely to get a blood clot in your veins as you get older and if
any of the following applies to you. Inform your doctor if any of these
situations applies to you:
• you are unable to walk for a long time because of major surgery, injury or
illness (see also section 3, If you need to have surgery)
2
• you are seriously overweight (BMI >30 kg/m )
• you have any blood clotting problem that needs long-term treatment with
a medicine used to prevent blood clots
• if any of your close relatives has ever had a blood clot in the leg, lung or
another organ
• you have systemic lupus erythematosus (SLE)
• you have cancer.
For signs of a blood clot, see “Stop taking Climagest and see a doctor
immediately”.
Compare
Looking at women in their 50s who are not taking HRT, on average, over a
5-year period, 4 to 7 in 1000 would be expected to get a blood clot in a vein.
For women in their 50s who have been taking oestrogen-progestogen HRT
for over 5 years, there will be 9 to 12 cases in 1000 users (i.e. an extra 5
cases).
Heart disease (heart attack)
There is no evidence that HRT will prevent a heart attack.
Women over the age of 60 years who use oestrogen-progestogen HRT are
slightly more likely to develop heart disease than those not taking any HRT.
Stroke
The risk of getting stroke is about 1.5 times higher in HRT users than in
non-users.
The number of extra cases of stroke due to use of HRT will increase with
age.
Compare
Looking at women in their 50s who are not taking HRT, on average, 8 in
1000 would be expected to have a stroke over a 5-year period. For women
in their 50s who are taking HRT, there will be 11 cases in 1000 users, over
5 years (i.e. an extra 3 cases).

Other conditions
HRT will not prevent memory loss. There is some evidence of a higher risk
of memory loss in women who start using HRT after the age of 65. Speak to
your doctor for advice.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have recently
taken any other medicines, including medicines obtained without a
prescription, herbal medicines or other natural products. Some medicines
may interfere with the effect of Climagest. This might lead to irregular
bleeding. This applies to the following medicines:
• medicines for epilepsy (such as phenobarbital, phenytoin,
carbamazepine),
• medicines for tuberculosis (such as rifampicin, rifabutin),
• medicines for HIV infection (such as nevirapine, efavirenz, ritonavir,
telaprevir, nelfinavir),
• herbal remedies containing St John’s wort (Hypericum perforatum).
Laboratory tests
If you need a blood test, tell your doctor or the laboratory staff that you are
taking Climagest, because this medicine can affect the results of some
tests.
Pregnancy and breast-feeding
Climagest is for use in postmenopausal women only. If you become
pregnant, stop taking Climagest and contact your doctor. Do not take
Climagest if you are pregnant or while you are breast-feeding.
Driving and using machines
Climagest has no known effects on the ability to drive and use machines.
Climagest contains lactose
Lactose is a form of sugar. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking
Climagest.

3) How to take Climagest
Always use this medicine exactly as your doctor has told you. Your doctor
will aim to prescribe the lowest dose to treat your symptom for as short as
necessary. Speak to your doctor if you think this dose is too strong or not
strong enough. During the treatment your doctor may adjust the dose
according to your individual needs.
When to start treatment
Climagest is a continuous sequential HRT. This means that oestrogen is
given continuously, and progestogen is added for 12 days of the cycle.
• If you are not currently taking HRT and still having periods, it is
advisable to take the first tablet on the first day of your period (first day of
the bleed) unless your doctor tells you otherwise. If your periods are
infrequent, or have stopped, your doctor may suggest that you start
immediately.
• If you are changing from a sequential HRT or cyclic HRT, you should
complete your treatment cycle and then start taking Climagest
immediately.
• If you are changing from a continuous combined HRT and your
periods have stopped, you can start taking Climagest at any time. If you
still have periods, start taking Climagest on the first day of your period.
How to take Climagest
Take one tablet each day by following the sequence of numbers and
arrows on the calendar pack.
Swallow your tablets whole with a glass of water.
The pack has been designed specifically to help you take the tablets
correctly.
Write the name of the day you take your first tablet in the box below. For
example, if you start your tablets on a Wednesday, then write “Wednesday”
in the box. This day will also be the day on which you will take tablets 8, 15
and 22. This will help you check that you have taken each tablet on the
right day.
Write your start day here:

When you finish one blister pack, start the new one the next day whether or
not you experience bleeding. This will normally be the same day of the
week as you started the previous blister pack. Do not take a break between
blister packs unless your doctor tells you.
The tablets are best taken at the same time every day; try to get into a
routine.
Follow your doctor’s instructions as to how and when you should take
Climagest tablets and never change the dose yourself, however well you
feel.
If you are unsure about how much medicine to take or when to take it, ask
your doctor or pharmacist.
How long to take Climagest
From time to time, you will need to discuss with your doctor the possible
risks and benefits associated with Climagest and whether you still need the
treatment. It is important that you take the lowest possible effective dose
and only for as long as needed.
If you have taken more Climagest than you should
Contact your doctor or pharmacist immediately if you have taken too much
Climagest.
If you forget to take Climagest
If you forget to take a tablet at your usual time, try to take it within 12 hours.
If this is not possible, leave the forgotten tablet and continue to take the
remaining tablets at the usual time.
If you need to have surgery
If you are going to have surgery, tell the surgeon that you are taking
Climagest. You may need to stop taking Climagest about 4 to 6 weeks
before the operation to reduce the risk of a blood clot (see section 2, Blood
clots in a vein). Ask your doctor when you can start taking Climagest again.
If you stop taking Climagest
Stopping Climagest may increase the risk of breakthrough bleeding or
spotting. If this occurs after you stop treatment, contact your doctor
immediately. Your doctor will need to work out the reasons for this.
After a long treatment break, consult your doctor before starting to take
Climagest again.
If you have any further questions on the use of this product, ask your doctor
or pharmacist.

4) Possible side effects
The following diseases are reported more often in women using HRT
compared to women not using HRT:
• breast cancer
• abnormal growth or cancer of the lining of the womb (endometrial
hyperplasia or cancer)
• ovarian cancer
• blood clots in the veins of the legs or lungs (venous thromboembolism)
• heart disease
• stroke
• probable memory loss if HRT is started over the age of 65
For more information about these side effects, see Section 2.
Like all medicines, this medicine can cause side effects, although not
everybody gets them.

Some effects could be serious
These symptoms need immediate medical attention:
• Unexpected vaginal bleeding or spotting (breakthrough bleeding) after
taking Climagest for some time, or after you stop treatment
• Painful menstrual periods
• Painful swelling and redness of the legs
• Sudden chest pain
• Difficulty in breathing
• Pain in your chest that spreads to your arm or neck
• Yellowing of the eyes and face (jaundice)
• Rapid increase in your blood pressure
• Unexplained migraine-like headaches
• Breast changes, including dimpling of the breast skin, changes in the
nipple, lumps that you can see or feel.
Stop taking Climagest and tell your doctor immediately if you get any of
the effects mentioned above. Check the risks to be aware of with HRT in
general in section 2, When to take special care with Climagest.
Other side effects
In addition, the following side effects have been reported with Climagest:
• Breast tension and pain, breast cancer.
• Discharge from the vagina.
• Headache, dizziness, vertigo, changes in sexual desire, depression.
• Increased blood pressure, palpitations (sensation of fluttering in the
chest), tender or painful veins (signs of thrombophlebitis), fluid retention,
nose bleeds.
• Indigestion, wind, nausea, vomiting, abdominal pain and bloating,
problems with your gall bladder (biliary stasis).
• General itching, hair loss, hives and skin rash.
• Glucose intolerance which can make you sweat or feel faint after eating.
• Weight gain.
• Fibroids (benign growth in the uterus).
• Pain in extremity.
The following side effects have been reported with other HRTs:
• gallbladder disease,
• various skin disorders:
– discoloration of the skin specially of face or neck known as “pregnancy
patches” (chloasma)
– painful reddish skin nodules (erythema nodosum)
– rash with target-shaped reddening or sores (erythema multiforme)
• decline in memory or mental ability
• diarrhoea
• dry eyes and contact lens discomfort
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This
includes any possible side effects not listed in this leaflet.
You can also report side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the
safety of this medicine.

5) How to store Climagest
Keep all medicines out of the sight and reach of children.
• Do not take Climagest after the expiry date printed on the carton, label
or blister strip. The expiry date refers to the last day of the month.
• Do not store above 25°C. Protect from light. Store in a dry place and do
not refrigerate.
• If the tablets become discoloured or show any other signs of
deterioration, you should seek the advice of your pharmacist who will
tell you what to do.
• Medicines should not be disposed of via wastewater or household
waste. Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.

6) Contents of the pack and other information
What Climagest contains:
Climagest 1mg Tablets: The active ingredient of the grey-blue tablets is
1mg oestradiol valerate. The active ingredients of the white tablets are 1mg
oestradiol valerate and 1mg norethisterone.
Climagest 2mg Tablets: The active ingredient of the blue tablets is 2mg
oestradiol valerate. The active ingredients of the pale yellow tablets are
2mg oestradiol valerate and 1mg norethisterone.
The other ingredients of the grey-blue or blue tablets are lactose
monohydrate, maize starch, povidone K30, magnesium stearate,
hypromellose, propylene glycol, indigo aluminium carmine lake (E132),
sodium dodecyl sulphate, sodium edentate, titanium dioxide (E171), and
talc.
The other ingredients of the white or pale yellow tablets are lactose
monohydrate, maize starch, povidone K30, magnesium stearate,
hypromellose, propylene glycol, indigo aluminium carmine lake (E132),
titanium dioxide (E171), yellow iron oxide (E172) and talc.
What Climagest looks like and contents of the pack
Climagest 1mg Tablets:
The estradiol valerate tablets are round, grey-blue, film-coated tablets
marked ‘OC’ on one side and ‘CG’ on the reverse.
The combination tablets (estradiol valerate and norethisterone) are round,
white, film-coated tablets marked ‘OE’ on one side, ‘CG’ on the reverse.
Climagest 1mg tablets are available as calendar blister packs of 28 or 84
tablets.
Climagest 2mg Tablets:
The estradiol valerate tablets are round, blue, film-coated tablets marked
‘OD’ on one side and ‘CG’ on the reverse.
The combination tablets (estradiol valerate and norethisterone) are round,
pale-yellow, film-coated tablets marked ‘OF’ on one side, ‘CG’ on the
reverse.
Climagest 2mg tablets are available as calendar blister packs of 28 or 84
tablets.
PL 10383/1186
PL 10383/1187

Climagest 1mg Tablets
Climagest 2mg Tablets

POM

Who makes and repackages your medicine?
Your medicine is manufactured by Novartis Pharma GmbH, 90429
Nurnberg, Germany. Procured from within the EU and repackaged by
Product Licence Holder: Primecrown Ltd., 4/5 Northolt Trading Estate,
Belvue Road, Northolt, Middlesex, UB5 5QS.
Leaflet date: 29.05.2015
®

Climagest is a registered trademark of Novartis AG, Basle, Switzerland.

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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